Sr. Specialist, Engineering

Job description

Job Description Our Animal Health Manufacturing teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local/regional plants connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products. The focus of a Senior Specialist within the Site Support (SS) team in the Bio Technology Solutions (BTS) department is on vaccine and biopharmaceutical process improvement, troubleshooting, technical investigations, and execution support for Animal Health manufacturing. The role supports complex commercial vaccine processes involving viral/vector-based and cell culture-based antigen manufacturing, downstream processing, sterile biopharmaceutical product fill-finish, supply continuity, and new process/product introductions, while also contributing technical support across other vaccine and biological manufacturing processes as business needs require. Within a multidisciplinary environment, you will collaborate with BTS-SS, BTS-PD, ATS, Operations, Engineering, Quality Control/Assurance, Supply Chain or Planning, Regulatory Affairs, Safety, and R&D to provide end-to-end technical support for commercial Animal Health manufacturing. Job Description: Lead and support optimization, troubleshooting, investigations, validation, and process improvement for Animal Health vaccine and biopharmaceutical manufacturing processes, including complex viral/vector-based, cell culture, downstream processing, blending, and sterile fill-finish operations. Provide technical support for complex commercial vaccine manufacturing by helping resolve production issues, reduce process variability, sustain supply continuity, and improve right-first-time execution, while supporting other Animal Health manufacturing areas as needed. Support technology transfer, new process/product introductions, comparability activities, and manufacturing improvements across site, global, and cross-functional teams. Resolve manufacturing challenges with urgency using scientific data and practical recommendations grounded in safety, quality, compliance, cost-efficiency, and consistent execution. Evaluate technical issues from multiple perspectives, including process, equipment, automation, people, materials, safety, and compliance, to identify and address root causes. Apply working knowledge of USDA regulatory guidelines, current GMP expectations, aseptic processing principles, standardized work, engineering controls, and process analytical technology. Develop project charters, plans, timelines, deliverables, risk mitigation plans, tracking tools, and stakeholder communications aligned with manufacturing and business needs. Coordinate team activities, lead or participate in core team meetings, communicate status and risks, and escalate issues or opportunities as needed. Author and execute experimental protocols, reports, and technical/manufacturing documents supporting laboratory or production evaluations, investigations, process design, engineering studies, change control, comparability, and validation. Demonstrate leadership, collaboration, business acumen, and effective communication while contributing to global projects, continuous improvement, EHS support, and training or guidance for employees and interns. Education Minimum Requirement: Bachelor of Science in Chemical Engineering, Biotechnology, Mechanical Engineering, Biochemistry, Protein Chemistry, or related field with at least 5 years of experience in vaccine and/or biopharmaceutical Development, Process/Product Development, and/or Biological manufacturing or closely related field. (Or Master of Science degree and at least 3 years of experience.) Required Experience and Skills: Direct experience supporting complex commercial vaccine processes involving viral/vector-based production, cell culture, downstream processing, and sterile fill-finish operations, with additional exposure to other Animal Health vaccine or biological manufacturing platforms. Excellent written and oral communication, documentation, and project management skills. Strong collaboration skills with experience working across commercial manufacturing teams and multidisciplinary stakeholders, including Operations, Engineering, Quality, Regulatory, Safety, Supply Chain, R&D, and global or site-based partners. Strong analytical, problem-solving, and decision-making skills, with a hands-on approach that incorporates safety, quality, compliance, process, equipment, automation, materials, and people considerations. Experience supporting complex commercial vaccine manufacturing or technical operations involving viral/vector-based or cell culture-based antigen production, downstream processing, sterile biopharmaceutical operations, and broader familiarity with other vaccine or biological manufacturing processes. Experience with process characterization, scale-up/scale-down, process robustness, technical troubleshooting, investigations, protocol execution, and validation support. Working knowledge of USDA regulatory guidelines, current GMP requirements, aseptic processing principles, and manufacturing/testing expectations for vaccine or biopharmaceutical products. Experience authoring and executing technical protocols and documents, including reports, investigation summaries, change control documentation, comparability assessments, and validation-related documentation. High degree of ownership, scientific rigor, urgency, and continuous improvement mindset in support of commercial manufacturing and supply continuity. Preferred Experience and Skills: Understanding of statistics and application to process monitoring, control, investigations, and manufacturing data analysis. Experience applying standardized work, engineering controls, process analytical technology, or protocol-driven studies to improve process robustness and manufacturing performance. Experience introducing, testing, or supporting new technologies, process changes, or improvement initiatives in manufacturing or technical support environments. Experience supporting global, multi-site, technology transfer, comparability, or launch-readiness projects. Schedule Requirements Able to work first shift, Monday through Friday as base schedule. Off-shift coverage may be required based on manufacturing and transfer activities. Required Skills: Experimentation, Experiment Planning, Laboratory Experiments, Laboratory Testing, Life Sciences R&D, Manufacturing Production, Manufacturing Scale-Up, Process Improvements, Process Scale Up, Technology Transfer Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We